K242010

Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

510(k) number: K242010
Device name: Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)
Applicant: Shenzhen Sanping Image Technology Co., Ltd. CN
Product code: EOQ — Bronchoscope (Flexible Or Rigid)
Decision date: 2025-03-14
Date received: 2024-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K242010.pdf

Official FDA record: K242010

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.